ArticleFrontiers in cardiovascular medicine2025
Single-centre, single-blind, randomized, active-controlled phase-3 non-inferiority study to investigate the safety and efficacy of the cardioplegic solution Cardioplexol™.
Article in Frontiers in cardiovascular medicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
1 citing paper in PubMed.
- A multi-center, open label, single group, observational clinical trial to investigate the effects of training on the administration of Cardioplexol™.Frontiers in cardiovascular medicine · 2025Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Objectives: Effective and reliable cardioplegic cardiac arrest is crucial for maximizing myocardial protection and preserving postoperative contractile function. Aim of this study was to demonstrate, in line with an ongoing European registration procedure, the efficacy and safety of the new Cardioplexol™ solution. Methods: Single-centre, single-blind, randomized, active-controlled phase-3 non-inferiority trial comparing Cardioplexol™ and Buckberg solutions during cardiac surgery. Patients planed for elective CABG, valve surgery and/or aortic root surgery, were considered eligible after meeting all inclusion and exclusion criteria. Peak troponin-T (TnT) during the first 24 h post-reperfusion was defined as primary endpoint. Intraoperative and ICU-related secondary endpoints were also evaluated, as were safety endpoints. Results: Out of 248 operated patients, 226 (100 Cardioplexol™, 126 Buckberg) were considered for per-protocol analysis. Peak-TnT was similar in both groups (0.77 vs. 0.78 ng/ml) and non-inferiority of Cardioplexol™ was confirmed. Delay before complete cardiac arrest (11 vs. 71 s, Conclusion: Efficacy and safety of Cardioplexol™ were demonstrated. Clinical Trial Registration: https://www.clinicaltrialsregister.eu/ctr-search/trial/2011-004198-10/results, Eudra CT-No: 2011-004198-10.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.